BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    DUPLOREACH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01408N0·Cervical Rasp, 15 x 12, 8mm, 0 Degree, No Taper

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033562772·

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01408T0·Cervical Rasp, 15 x 12, 8mm, 7 Degree, Tapered

    ATAC PAK AST REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 12, 2017

    GOOD SAM CINCINNATI OH 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.,·Product code JOH·July 16, 2016

    BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016

    BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 27, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD)·Product code KNT·March 14, 2008

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·February 12, 2014

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 5, 2024

    DIALYSIS UNKNOWN

    FDA Adverse Event
    Injury ·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·October 17, 2022

    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.

    FDA Recall
    Terminated ·ITC-Nexus Dx·Product code GFO·December 19, 2013